Fail safe point protector for needle safety flap

ABSTRACT

A method and device are disclosed for preventing a needle stick hazard in the event of a collapse of a protective needle flap of a portable drug pump. The device may include a needle guide, a secure space and/or a shield. A point of a needle is optionally deflected into a secure space upon collapse of the protective flap. The space may optionally be shielded. Optionally, the support linking the needle to the pump may pivot and/or translate. Optionally, there may be an exposing position wherein the needle protrudes through an opening in the flap. Optionally, the opening may be non-circular.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S application Ser.No. 14/715,791, filed May 19, 2015, entitled “Fail Safe Point ProtectorFor Needle Safety Flap,” which is a continuation of U.S. applicationSer. No. 13/429,840, filed Mar. 26, 2012, entitled “Fail Safe PointProtector For Needle Safety Flap,” now U.S. Pat. No. 9,072,827, issuedJul. 7, 2015, the disclosure of each of which is incorporated herein byreference in its entirety.

BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to a systemand method for preventing a reexposure of point of a needle bydeflecting the point and more particularly, but not exclusively, to aguide and/or a safety clip for deflecting and/or enclosing the pointupon collapse of a needle protector flap.

International Patent Application WO 2011090955 to Oz Cabiri discloses aneedle assembly adapted for fluid communication with a cartridgecontaining a substance to be delivered to a subject, the needle assemblyis characterized by a biasing device arranged to apply a biasing forceon a needle to cause the needle to protrude outwards of a housing topierce the subject. A safety latch is movably mounted on the housing andformed with a needle opening to allow the needle to pass therethrough.The safety latch has a first position wherein the needle is aligned topass through the needle opening and a second position wherein the safetylatch is moved with respect to the housing and the needle is blocked bya portion of the safety latch distanced from the needle opening.

U.S. Pat, No. 5,300,045 and International Application WO 2008/014908 toPlassche discloses a stylet which is received in a needle cannula and isautomatically capped in a guard body when the stylet is withdrawn fromthe cannula. The guard contains an arm which moves into blockingposition with respect to the tip of the stylet when it is withdrawn fromthe cannula by following a cam surface on the cannula hub (either insideor outside the hub for different styles of needle cannulas). The arm maybe spring biased, across a hole in the guard in which the stylet isslidably disposed into interfering relationship with the arm. The camsurface urges the arm to bring a portion thereof which protects thepoint of the tip of the stylet and captures it inside the guard. The armand cam prevent removal of the stylet from the cannula until the tip iscovered and protected by the guard, thereby automatically capping thetip of the stylet to prevent potentially dangerous, inadvertent, oraccidental sticking of medical personnel.

U.S. Pat. No. 5,836,920 to Robertson discloses a guard for a hypodermicneedle that includes a hub for attachment to a needle and a shield whichcan be attached to the hub. The shield is adapted to lie adjacent theneedle and has a lip which projects outwardly to cover the tip of theneedle. An enclosure for the tip of the needle is provided and locatedadjacent to the lip. The hub and the shield each includes complementaryattachment mechanisms whereby the shield can be attached to the hub infirst and second relative positions. In the first position, the needlecan be used and the shield is capable of moving away from the needle touncover the tip as the needle initially penetrates the body of a patientand of returning back toward the needle and again to cover the tip asthe needle is withdrawn from the patient. By pulling the shield towardthe hub in a direction substantially parallel to the longitudinal axisof the needle, the shield is attached to the hub in a second relativeposition wherein the tip of the needle is enclosed by the enclosure andthereby locks the shield in position with respect to the needle so thatthe shield cannot be flexed away from the needle to uncover the tipafter use.

U.S. Published Patent Application, 2011/0282296 to Harms discloses aprotective cap coupled to a syringe having a needle attached thereto.The protective cap may be pivoted to a position in alignment with theneedle so that the protective cap substantially envelops the needle. Aplug may be inserted into the cap to envelop or capture the needlewithin a hollow body of the plug to secure at least a tip of the needle.

Additional background art includes U.S. Published Patent Application2010/0168683 to Oz Cabiri, U.S. Published Patent Application2010/0234767 Sarstedt, U.S. Published Patent Application 2008/0208138 toKiang, U.S. Published Patent Application 2003/0135159 to Daily, U.S.Published Patent Application 2002/0055711 to Lavi, U.S. Pat. No.8,057,431 to Woehr, U.S. Pat. No. 7,854,723 to Hwang, U.S. Pat. No.6,224,569 to Brimhall, and U.S. Pat. No. 4,929,241 to Kulli.

BRIEF SUMMARY OF THE INVENTION

According to an aspect of some embodiments of the present inventionthere is provided a device for preventing reexposure of a point of aneedle projecting from a housing of an apparatus wearable by a recipientfor delivering a drug to the recipient. The device may include a flapmovably mounted to a housing of the apparatus. The flap may have aprotecting position in which the flap may cover the point. The devicemay further include a secure space. The device may further include aguide integrated into the flap. The guide may be positioned relative tothe point such that upon collapse of the flap the guide deflects thepoint into the secure space thereby preventing the reexposure of thepoint upon the collapse.

According to some embodiments of the invention, in the protectingposition, the guide may be disposed at an incline to the needle. Theincline may be at an angle of between 5 and 85 degrees to the needle

According to some embodiments of the invention, the device may furtherinclude a clip shielding the secure space.

According to some embodiments of the invention, after the collapse ofthe flap, the secure space may be shielded by a clip and/or the flapand/or a joint between the flap and the housing.

According to some embodiments of the invention, the device may furtherinclude a pivot linking the needle and the housing. The pivot may bepositioned to rotate upon deflection of the needle.

According to some embodiments of the invention, the device may furtherinclude a translating support linking the needle and the housing. Thetranslating support may be positioned to translate upon deflection ofthe needle.

According to some embodiments of the invention, the guide may bepositioned to bend the needle when the needle is deflected.

According to some embodiments of the invention, the guide may include achannel positioned to direct the point of the needle toward the securespace.

According to some embodiments of the invention, the guide may include abarrier positioned to direct the point to the secure space.

According to some embodiments of the invention, the flap may bepivotally connected to the housing of the apparatus.

According to some embodiments of the invention, the flap may have anexposing position wherein the needle protrudes through an opening in theflap. The opening may be non-circular.

According to some embodiments of the invention, the device may furtherinclude a biasing device for moving the flap from the exposing positionto the protecting position.

According to some embodiments of the invention, in the protectingposition, the opening may be not aligned with the point.

According to an aspect of some embodiments of the present inventionthere is provided a device for preventing reexposure of a point of aneedle projecting from a housing of an apparatus.

The apparatus may be wearable by a recipient. The apparatus may delivera drug to the recipient. The device may include a flap movably mountedto the housing of the apparatus. The flap may have at least threepositions: an exposed position in which the needle protrudes through anopening in the flap; and a protecting position in which the flap coversthe point and the point is not aligned with the opening; and a collapsedposition. The device may also include a secure location in the collapsedposition. The device may also include a guide integrated into the flap.The guide may be positioned relative to the point of the needle suchthat upon movement of the flap from the protecting position to thecollapsed position the guide deflects the point into the secure spacethereby preventing the reexposure of the point upon collapsing of theprotective flap.

According to some embodiments of the invention, in the protectingposition, the guide may be disposed at an incline to the needle.

According to some embodiments of the invention, the incline between theguide and the needle in the protected position may be at an angle ofbetween 5 and 85 degrees.

According to some embodiments of the invention, the device may furtherinclude a clip shielding the secure space.

According to some embodiments of the invention, after the collapse ofthe flap, the secure space may be shielded by a clip and/or the flapand/or a joint between the flap and the housing of the apparatus.

According to some embodiments of the invention, the device may furtherinclude a pivot linking the needle and the housing. The pivot may bepositioned to rotate when the needle is deflected.

According to some embodiments of the invention, the device may furtherinclude a translating support linking the needle and the housing. Thetranslating support may be positioned to translate upon deflection ofthe needle.

According to some embodiments of the invention, the guide may bepositioned to bend the needle upon the deflection of the needle.

According to some embodiments of the invention, the guide may include achannel positioned to direct the point of the needle toward the securespace.

According to some embodiments of the invention, the guide may include abarrier positioned to direct the point of the needle toward the securespace.

According to some embodiments of the invention, the flap may bepivotally connected to the housing.

According to some embodiments of the invention, the device may furtherinclude a biasing device for moving the flap from the exposing positionto the protecting position.

According to some embodiments of the invention, the needle opening inthe flap may be non-circular.

According to an aspect of some embodiments of the present inventionthere is provided a method of preventing reexposure of a point of aneedle projecting from a housing of a portable injection apparatus uponcollapse of a protective flap. The method may include covering the pointafter use of the apparatus by moving the protective flap to a protectingposition, and deflecting the point into a secure space upon a collapseof the protective flap to prevent the reexposure of the point.

According to some embodiments of the invention, the method may furtherinclude shielding the secure space.

According to some embodiments of the invention, the method may furtherinclude pivoting the needle around a needle support when the needle isdeflected. The needle support may link the needle and the housing.

According to some embodiments of the invention, the method may furtherinclude translating a needle support that links the needle and thehousing upon the deflection of the needle.

According to some embodiments of the invention, the method may furtherinclude bending the needle upon the deflection of the needle.

According to some embodiments of the invention, the method may furtherinclude pivoting the protective flap from an exposing position whereinthe needle protrudes through an opening in the protective flap to theprotecting position.

According to an aspect of some embodiments of the present inventionthere is provided a device for preventing a needle stick by a point of aneedle projecting from a housing of an apparatus wearable by a recipientfor delivering a drug to the recipient. The device may include a flapmovably mounted to a housing of the apparatus. The device may alsoinclude a non-circular opening in the flap. The needle may projectthrough the non-circular opening when the flap is in an exposingposition. The device may further include a biasing mechanism for movingthe flap to a protecting position in which the flap covers the point andthe non-circular opening is not aligned with the point.

According to an aspect of some embodiments of the present inventionthere is provided a device for preventing a needle stick by a point of aneedle projecting from a housing of an apparatus wearable by a recipientfor delivering a drug to the recipient. The device may include a flapmovably mounted to a housing of the apparatus and an opening in theflap. The needle may project through the opening when the flap is in anexposing position. The device may also include a biasing mechanism formoving the flap to a protecting position in which the flap covers thepoint of the needle. In the protecting position, the opening may not bealigned with the point. The device may also include a translating needlesupport linking the needle and the housing.

According to an aspect of some embodiments of the present inventionthere is provided a device for preventing a needle stick by a point of aneedle projecting from a housing of an apparatus wearable by a recipientfor delivering a drug to the recipient. The device may include a flapmovably mounted to a housing of the apparatus and an opening in theflap. The needle may project through the opening when the flap is in anexposing position. The device may also include a biasing mechanism formoving the flap to a protecting position in which the flap covers thepoint of the needle. In the protecting position, the opening may not bealigned with the point. The device may also include a pivoting needlesupport linking the needle and the housing.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofthe invention, will be better understood when read in conjunction withthe appended drawings. For the purpose of illustrating the invention,there are shown in the drawings embodiments which are presentlypreferred. It should be understood, however, that the invention is notlimited to the precise arrangements and instrumentalities shown.

In the drawings:

FIG. 1a is a flow chart illustrating an exemplary method according tothe current invention;

FIG. 1b is a flow chart illustrating an exemplary method according tothe current invention including extra optional steps;

FIG. 2a is a simplified cutaway illustration of an exemplary embodimentdrug pump attached to a recipient with a flap in an exposing position;

FIG. 2a ′ is a perspective illustration of an exemplary embodiment drugpump with a flap in an exposing position;

FIG. 2b is a perspective view of the embodiment of FIG. 2a with the flapin a protecting position;

FIGS. 2c and 2c ′ are a close up cutaway view of the flap aftercollapse;

FIG. 2d is a perspective view of the flap;

FIG. 3a is a perspective view of the embodiment of FIG. 2 with the flapin a protecting position;

FIG. 3b is a view of the embodiment of FIG. 2 with the flap in aprotecting position, from another perspective;

FIG. 3c is a cutaway illustration of the embodiment of FIG. 2 with theflap in the protecting position;

FIG. 3d is a perspective view of the base of the apparatus of FIGS. 2a-d, FIGS. 3a-c with the flap in the exposing position showing the form ofthe needle opening.

FIG. 3d ′ is a close up base view of oval A of FIG. 3d showing the formof the needle opening.

FIG. 4 is a cutaway view of the embodiment of FIGS. 2a-d, 3a-d aftercollapse of the protective flap;

FIG. 4′ is an expanded view of circle B of FIG. 4;

FIG. 5a is a cutaway view of an additional embodiment of an injectorwith a flap in a protecting position;

FIG. 5b is a cutaway view of the embodiment of FIG. 5a after collapse ofthe flap;

FIG. 6a is a cutaway view of a further additional embodiment of aninjector with a flap in a protecting position;

FIG. 6b is a cutaway view of the embodiment of FIG. 6a after collapse ofthe flap;

FIG. 7 is a perspective view of a further alternative embodiment of aflap, and

FIG. 8 is a perspective view of a further alternative embodiment of aguide.

DETAILED DESCRIPTION OF THE INVENTION

The present invention, in some embodiments thereof, relates to a systemand method for preventing a reexposure of point of a needle bydeflecting the point and more particularly, but not exclusively, to aguide and/or a safety clip for deflecting and/or enclosing the pointupon collapse of a needle protector flap.

A portable drug pump may include a protective flap for covering aprotruding needle. Under certain conditions, the protective flap maycollapse, reexposing the needle. In some embodiments, the presentinvention may include an optional guide for deflecting the needle to asecure space thereby preventing reexposure of the needle in the event ofcollapse of the flap. An optional enclosure may shield the secure space.

In some embodiments, in a protecting position, when the flap is in theprotecting position, the guide may be disposed at an incline to theneedle. The angle of include between the deflective guide and the needlemay determine the direction to which the point will be deflected uponcollapse of the flap. The angle between the needle and the deflectiveguide may optionally range between 5° to 85°. The guide may take a formof a flat plate and/or the guide may include walls and/or a channel fordirecting the needle tip to the secure space and/or the guide may have aconcave form for directing the needle tip.

In some embodiments, deflecting the point will include bending a needle.Additionally or alternatively, deflecting the point may include pivotingthe needle and/or causing a translation of the support of the needle.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

FIG. 1 a is a flow chart illustrating a simplified example of a methodfor preventing reexposure of a point when a protecting flap is subjectto a collapse failure. Such a failure may result, for example, from astrong blow to the flap.

An injection apparatus may be used, for example, by a patient who needsto receive a drug by subcutaneous injection. The patient may prefer toreceive the injection at home using the injection apparatus rather thantraveling to a doctor. The recipient may wear the injector by optionallyattaching 162 the apparatus to his body. Attachment 162 may be, forexample, by means of an adhesive on the base of the injector.

In some embodiments, after attachment 162 the injector may optionallyinsert 164 a hypodermic needle subcutaneously into the recipient. Theinjection apparatus may then optionally inject 166 the drug through theneedle into the recipient. After injection 166, the patient optionallyremoves 168 the injection apparatus.

In some embodiments, after removal 168, the needle will remainprotruding from the injection apparatus, presenting a needle stickhazard. In order to protect people from the needle, the injectionapparatus may optionally include a protective flap for covering 170 theneedle.

When the flap is in a protecting position, at times, a strong force maycollapse 172 the protecting flap. For example, the patient may throw theapparatus into the garbage and then later compact the garbage with hisfoot. The compaction force may collapse the protective flap of theinjection apparatus, possibly reexposing the sharp tip of the needle.

In some embodiments, the flap may include an optional fail-safe guide toprevent reexposure of the needle in the event of collapse 172 of theflap. The guide may optionally deflect 174 a point of a needle into asecure space, reducing the likelihood of a needle stick injury.

FIG. 1b is a flow chart illustrating a method of averting a needle stickincluding optional steps. A method of averting needle sticks may includeone, some or all of the optional steps.

An injection apparatus is supplied in a protecting 170′ position whereina needle protecting flap covers the point. When a strong force collapsed172′ the protecting flap, the point is optionally deflected 174′ into asecure space.

In the exemplary embodiment of FIG. 1b , the point may optionally be ona tip of a needle. The needle may optionally be bent 176 duringdeflection 174′. Alternatively or additionally, the needle may bemounted on a movable support and the needle may pivot and/or translatewhile the point is being deflected 174′.

In some cases, a shield (for example a clip) may be included in theinjector for shielding 178 the secure space. Shielding 178 the securespace may prevent needle sticks, for example, when the flap breaksand/or a person pushes his finger under the flap and/or when thedisplacement of the flap uncovers the needle and/or when the point isdisplaced away from under the flap by bending and/or pivoting and/ortranslating. Alternatively or additionally, the needle and/or the guideand/or the clip may hold 180 the needle protective flap in a closedposition, thereby shielding 178 the needle with the flap.

FIGS. 2a, 2a ′, 2 b, 2 c, 2 c′, 2 d, 3 a, 3 b, 3 c, 3 d, 3 d′, 4 and 4′are views of an exemplary embodiment 210 of a portable drug injectorapparatus and a needle protection flap 222. In embodiment 210, flap 222is optionally pivotally mounted to a base of the apparatus housing.

FIGS. 2a-c are a simplified illustration of a needle protector invarious positions. Particularly, FIGS. 2a, a ′ illustrate the injectorand flap in an exposing position, wherein needle 216 is exposed. Forexample, in FIG. 2a , flap 222 is shown in the exposing position whilethe apparatus is injecting a drug into a flesh 205 of a recipient. FIG.2b illustrates the injector in a protecting position. FIGS. 2c, c ′illustrate the injector after collapse of protective flap 222.Particularly, FIG. 2c ′ illustrates a secure space 256 and a guide 252for deflecting a point 232 of needle 216 into the secure space. FIG. 2also shows an optional clip 254 shielding secure space 256.

FIG. 2a, a ′ illustrates protective flap 222 in an exposing position(for example while injecting a drug into a patient). In FIG. 2a , theembodiment 210 is shown attached to a recipient.

Needle 216 projects out of a needle opening 229 in flap 222 and isinserted into flesh 205. During injection, the base of the injector istypically held against the skin of the recipient by an adhesive. In theexposing position, flap 222 is optionally held flush to the base of theinjector housing by pressure against skin of the recipient. Needle 216is optionally locked in the protruding position. The drug may beadministered to the recipient, for example, via needle 216 and/or acannula.

Embodiments of the invention are described with reference to a needlealone, but apply as well to a needle disposed in a cannula or any otherdelivery device. The term “needle” is used throughout the specificationand claims to encompass all such delivery devices and/or sharpimplements.

Embodiment 210 typically includes a motor, a battery and a control unit(all not shown) within the housing of the apparatus. After needle 216has penetrated the skin of the patient, the control unit controlsoperation of the motor to administer a controlled amount of thesubstance to the patient at a controlled rate of delivery. Of course,the needle assembly of the present invention can be used in otherapplications and does not have to be used with a controlled motorizeddelivery system.

When injection has finished the injector is lifted away from the skin ofthe recipient and flap 222 pivots away from the base of the apparatus toa protecting position as illustrated, for example, in FIG. 2b (and inmore detail in FIGS. 3a-c ). In the protecting position, flap 222 coversthe point of needle 216 protecting from a needle stick hazard.

There is a concern that if flap 222 is pivoted back toward the injectorhousing with a force sufficient to bend needle 216, then point 232 maybe reexposed creating a needle stick hazard. For example, in FIGS. 2band 2c if needle 216 were bent leftward toward the open space betweenflap 222 and the housing base without any protective mechanism a personcould get stuck if he pushed his fingers under the flap, as shown inFIG. 2c . Embodiment 210 includes a guide and clip to deflect and shieldneedle 216 and prevent such needle sticks as illustrated, for example,in FIG. 2c ′.

FIG. 2c ′ is an expanded cutaway illustration of the exemplaryembodiment of flap 222. Particularly, FIG. 2c ′ illustrates an optionalguide 252 and an optional clip 254 and an optional secure space 256,which prevent reexposure of needle 216 in the event of collapsing offlap 222.

Particularly, upon collapse of flap 222, guide 252 pushes needle 216into secure space 256. Optionally, clip 254 shields secure space 256.(See below more detailed discussion of the exemplary embodiment of guide252, clip 254, and space 252 in reference to FIGS. 4 and 4′.)

FIG. 2d shows a perspective view of flap 222.

In FIGS. 3a-c , embodiment 210 is shown in the protecting position.After finishing the drug administration, embodiment 210 is typicallylifted off the recipient's body. As the injector is lifted, biasingdevice 227 to pushes flap 222 away from the base of the apparatus. Flap222 pivots into the protecting position. In FIGS. 3a-c , flap 222 isshown in the protecting position, covering point 232.

As illustrated, for example, in FIG. 3c , as flap 222 moves from theexposing position (FIGS. 2a, a ′) into the protecting position (FIGS.2b, 3a-c ), a needle opening 229 optionally follows a curved trajectory330 (downward and rightward in FIG. 3c ). As opening 229 moves alongtrajectory 330, needle 216 is optionally flexed elastically rightward.When opening 229 passes below point 232, needle 216 optionally snapsback leftward to its un-stressed shape. As illustrated, for example, inFIG. 3c , in its unstressed shape, needle 216 optionally remains lockedprotruding out of the housing. Needle 216 is no longer aligned withneedle opening 229. Needle 216 optionally serves as a prop, preventingflap 222 from returning to the exposing position. Flap 222 serves as aprotector blocking point 232.

In FIG. 3d, d ′, it is seen that, in exemplary embodiment 210, opening229 is optionally non-circular. In some embodiments, the form of needleopening 229 may be selected to adjust resistance to pivoting of flap 222from the exposing position (FIGS. 2a, a ′, 3 d, d′) to the protectingposition (FIGS. 3a-c ). Additionally or alternatively, the form ofneedle opening 229 may be selected to adjust stability of flap 222 inthe protecting position.

In embodiment 210, opening 229 optionally includes a linear duct 240. Inembodiment 210, duct 240 is optionally directed at an angle 220 ofapproximately 55° with a pivoting axis 242 of flap 222.

In exemplary embodiment 210, as flap 222 pivots from the exposingposition (for example, as illustrated in FIG. 2a, a ′, 3 d, d′) into theprotecting position (for example, as illustrated in FIGS. 3a-c ), needle216 slides along duct 240 flexing to remain in opening 229. Once flap222 has pivoted far enough, point 232 passes through opening 229 andneedle 216 returns to its un-stressed shape (as illustrated, forexample, in FIG. 3c ).

In embodiment 210, the resistance of flap 222 to pivoting may increaseas the required flexing of needle 216 increases. The flexing required ofneedle 216 may depend on the length and angle 220 of duct 240.Generally, the resistance may decrease as angle 220 increases from 0° to90°.

In the protected mode of embodiment 210 (FIG. 3a-c ), as long as point232 is not aligned with opening 229, needle 216 acts as a prop tostabilize flap 222. The likelihood that point 232 will unintentionallyrealign with opening 229 may increase as angle 220 increases from 0° to90°.

Optionally, angle 220 may range between 5° and 85°. In many embodiments,angle 220 may range between 40° and 80°. In some embodiments, duct 240may be curved and/or have a non-uniform width. Optionally opening 229may have a different form. More generally, the flexing required ofneedle 216 may depend on the angle and distance between the un-stressedlocation of needle 216 and the contact point between needle 216 andopening 229 at the point of maximum flexing. More generally, thelikelihood of unintentional alignment, in the protecting position,between needle 216 and opening 229 may depend on the distance betweenthe unstressed location of point 232 and the closest edge of opening229, in the protecting position.

FIG. 3c illustrates an exemplary embodiment of an optional guide 252 andan optional enclosure, safety clip 254. Guide 252 is optionallyintegrated into flap 222. For example, guide 252 may be attached to flap222 and/or it may be integral to flap 222.

Under some conditions flap 222 may collapse. For example, a strong forcemay cause flap 222 to collapse and pivot towards the base of theapparatus. As flap 222 pivots, guide 252 deflects point 232 into asecure space 256 of clip 254 (as shown in FIGS. 4 and 4′), preventing aneedle stick hazard.

In some embodiments, clip 254 optionally shields secure space 256.Additionally or alternatively, clip 254 may clasp point 232.

In the protecting position of FIG. 3a-c , guide 252 is optionallydisposed at an approximately 45° angle 318 to the axis of needle 216 andpoint 232. In some embodiments, guide may be disposed at an angle 318ranging between 5° and 85° to point 232.

FIG. 4 shows embodiment 210 in after collapse of flap 222. FIG. 4′ showsan enlarged view of circle B. In FIGS. 4, and 4′ guide 252 has deflectedpoint 232 into protected secure space 256. In embodiment 210, guide 252is optionally configured so that deflection is in the direction awayfrom the joint between flap 222 and the injector housing. In alternativeembodiments, the needle may be defected towards the joint and/or at anangle to the pivoting connection.

In some embodiments, Clip 254 may be optionally configured to clasp bentneedle 216 thereby securing protective flap 222 in a closed position. Inthe closed position, flap 222 may shield point 232. In some embodimentsclip 254 may retain point 232 inside of secure space 256. For example,clip 254 may grasp needle 216 and/or point 232 (with a clasping force).Alternatively or additionally clip 254 may enclose and shield point 232but not grasp needle 216 or point 232.

The composition of clip 254 and/or guide 252 may include plastic, metal,paper, wood and/or another suitable material.

FIGS. 5a, b illustrate another exemplary embodiment 510 of an apparatus.In embodiment 510, upon collapse of an optional protective flap 522, aneedle 516 pivots into a secure space 556.

In embodiment 510, needle 516 is optionally mounted on a pivotingsupport 558. FIG. 5a shows embodiment 510 in a protecting position. FIG.5b shows embodiment 510 after collapse of flap 522.

In FIG. 5a , a point 532 is covered by flap 522. An optional guide 552is optionally inclined at an angle 518 with respect to point 532. Flap522 is held in the protecting position by an optional biasing device 527and by needle 516.

Under some conditions flap 522 may be forced to pivot back towards thebase of the apparatus. As flap 522 pivots toward the base of theapparatus, guide 552 deflects point 532 into a secure space 556. Atfirst, pivoting support 558 allows needle 516 to pivot without bending.As flap 522 collapses further, point 532 collides with the back side ofan optional clip 554 forcing needle 516 to bend as shown in FIG. 5 b.

FIGS. 6a,b illustrate another exemplary embodiment 610 of an apparatushaving fail-safe needle protection according to the current invention.Optionally, in embodiment 610, upon collapse of flap 622, point 632 isdeflected into a secure space 656 formed at the joint between flap 622and the housing of the apparatus.

In FIGS. 6 a,b, a needle 616 is mounted on an optional sliding pivotingsupport 658. Pivoting and translating of support 658 allows a point 632to be deflected into secure space 656 without bending needle 616.

FIG. 6a shows embodiment 610 in a protecting position. FIG. 6b showsembodiment 610 after collapse of an optional protective flap 622.

In FIG. 6a , a point 632 is covered by flap 622. Flap 622 is held in aprotecting position by an optimal biasing device 627 and by needle 616.An optional guide 652 is optionally held inclined at an angle 618 withrespect to point 632. In embodiment 610, the inclination of guide 652 isoptionally opposite that of flap 622.

Flap 622 may sometimes be forced to pivot back towards the base of theapparatus. As flap 622 pivots toward the base of the apparatus, guide652 deflects point 632 away from the opening between flap 622 and thebase of the apparatus. Point 632 is deflected towards secure space 656formed by the joint between flap 622 and the housing base. Support 658optionally pivots and translates along an optional track 660 allowingneedle 616 to pivot towards secure space 656. As flap 622 continues tocollapse, point 632 is pushed by guide 652. Eventually, needle 616pivots without bending until it lies flat up against guide 652 parallelto the base of the apparatus. In FIG. 6b , point 632 is located insecure space 656 shielded by the base of the apparatus and flap 622.

FIG. 7 is a close up perspective view of a further exemplary embodimentof a protective flap 722. Visible in the drawing are exemplaryembodiments of a pivoting axis 742 and a needle opening 729 and a guide752 and a shielding clip 754 and a secure space 756 and a biasingelement 727. Embodiment 722 also includes barriers 762 forming a channelfor preventing a needle from twisting sideward during a collapse of flap722.

FIG. 8 is a close up perspective view of an exemplary embodiment of aguide 852. Visible in the drawing are exemplary embodiments of a needleopening 829 and a shielding clip 854 and a secure space 856 and achannel 860 for directing the a needle point to secure space 856 and/orfor preventing a needle from twisting sideward during a collapse of aprotecting flap. Alternatively or additionally channel 860 may have anon-rectangular shape (for example, it could have a wedge shape).Alternatively or additionally channel 860 could have a non-rectangularcross-section (for example it could have a V shaped cross section).Alternatively or additionally, channel 860 could be formed by a concaveshape of guide 856.

It is expected that during the life of a patent maturing from thisapplication many relevant technologies will be developed and the scopeof the terms is intended to include all such new technologies a priori.

As used herein the term “about” refers to ±10%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

The term “consisting essentially of” means that the composition, methodor structure may include additional ingredients, steps and/or parts, butonly if the additional ingredients, steps and/or parts do not materiallyalter the basic and novel characteristics of the claimed composition,method or structure.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed, but itis intended to cover modifications within the spirit and scope of thepresent invention as defined by the appended claims.

I/we claim:
 1. An injection apparatus wearable by a recipient fordelivering a drug to the recipient, the injection apparatus comprising:a housing having a base, the base engaging skin of the recipient duringinjection; a generally linear needle having a needle point projectingfrom the housing; a flap pivotably mounted to the base of the housing,the flap including a bottom wall and a clip extending therefrom, asecure space located between the clip and bottom wall, the flap having:an exposed position, generally co-planar with the base, wherein at leastthe needle point is aligned with and protrudes through an aperture inthe flap, a protecting position, wherein the flap is pivoted away fromthe exposed position in a direction away from the base of the housingand covers the needle point, such and the needle point is positionedbetween said flap and said base and is not aligned with the aperture,and a collapsed position, wherein the flap is pivoted toward the base ofthe housing from the protecting position to a position in between theprotecting and exposed positions; wherein upon pivoting of the flap fromthe protecting position to the collapsed position, the flap moves theneedle point into the secure space within the flap, and wherein the flapfurther includes at least one barrier wall extending toward the basepositioned to prevent the needle from twisting sideward beyond thebarrier wall during pivoting of the flap from the protecting position tothe collapsed position, thereby preventing re-exposure of the needlepoint beyond the flap.
 2. The injection apparatus of claim 1, whereinthe at least one barrier wall comprises two parallel barrier wallsprojecting from the flap and defining a channel therebetween, alongitudinal axis of the needle being positioned between the two barrierwalls.
 3. The injection apparatus of claim 1, further comprising a guideattached to the flap, the guide being positioned relative to the needlepoint such that upon pivoting of the flap from the protecting positionto the collapsed position the guide bends the needle to a non-linearorientation, thereby deflecting the needle point into the secure spacewithin the flap.
 4. The injection apparatus of claim 1, furthercomprising a biasing device positioned between the flap and the housingfor moving the flap from the exposed position to the protectingposition.